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An Observational Cohort Study of Early Response to Therapy and Safety of Crisugabalin Besilate Capsules for the Treatment of Neuropathic Pain in the Real World

An Observational Cohort Study of Early Response to Therapy and Safety of Crisugabalin Besilate Capsules for the Treatment of Neuropathic Pain in the Real World

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100765
Enrollment
Unknown
Registered
2025-04-15
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropathic pain

Interventions

Cliga Bahrain besylate capsule group:None

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.able to understand and voluntarily sign a written informed consent form (ICF); 2.Age >= 18 years old; 3.Patients with a confirmed diagnosis of neuropathic pain combined with medical history, physical examination and necessary ancillary tests, DN4 >= 4 points; 4.First-time use of crisugabalin besilate capsules;

Exclusion criteria

Exclusion criteria: 1.participation in any other clinical study within 30 days prior to screening; 2.other conditions that, in the judgement of the investigator, make participation in this study inappropriate;

Design outcomes

Primary

MeasureTime frame
Change from baseline in daily NRS scores over 1 week;Change from baseline in pain NRS score at 4 weeks;

Secondary

MeasureTime frame
Change from baseline in daily NRS score and DSIS score over 4 weeks;Change from baseline in DSIS score at 1 week;Change from baseline in SF-MPQ (with VAS) scores at weeks 1 and 4;Adverse events within 4 weeks;

Countries

China

Contacts

Public ContactDaying Zhang

The first affiliated hostipal of nanchang university

zdy@medmail.con.cn+86 791 88692748

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026